Pharma Qualitätssicherung incl Validierungen, Sachkundige Person AMG (QP), GMP-Audits, PQRs, CMC-RA -Projekte,
Aktualisiert am 15.11.2024
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Verfügbar ab: 15.12.2024
Verfügbar zu: 30%
davon vor Ort: 100%
Sachkundige Person AMG (QP) zur Chargenfreigabe, PQRs,
GMP-Audits, RA:CMC-Projekte

Einsatzorte

Einsatzorte

Frankfurt am Main (+100km) Cochem (+75km) Bonn (+75km) Darmstadt (+75km)
nicht möglich

Projekte

Projekte

4 Jahre 8 Monate
2020-03 - 2024-10

Sachkundige Person AMG/ Leiter d. QK

QP / L. d. Qk
QP / L. d. Qk
10 Monate
2019-03 - 2019-12

Prozessvalidierungen Downstreram im Biotech.-Bereich

QA-MAnager
QA-MAnager
Frankfurt/M.
3 Monate
2017-10 - 2017-12

Bewertung/ Trending analytischer Daten von Chargen für PQR/ APR

Trending Expert
Trending Expert
8 Monate
2016-08 - 2017-03

Supporting Quality Assurance, Directorate GMP and Inspections

PQR Manager
PQR Manager
  • Filing and establishing of PQRs/ APRs,  Particular chapters: assessment of analytical test results of batches with evaluation of trending charts (process verification), stability tests, deviation management and CAPA, final conclusion
Merck KG a. A.
Darmstadt
4 Monate
2016-02 - 2016-05

Supporting a QP Unit within Product Quality Assurance

  • Filing and establishing of PQRs/ APRs,
  • Particular chapters: compilation of analytical test results of manufactured batches with detailed assessment of trending charts (process verification), stability tests and complaints, deviation management and CAPA, final conclusion
Boehringer Pharma GmbH & Co KG
Ingelheim
11 Monate
2015-02 - 2015-12

Reg. Affairs Manager for national and international procedures (MRP/ DCP)

  • Maintenance and renewals of marketing authorisations, variations (Labelling, SmPC and technical-analytical changes within CMC documents )
  • MAH transfers world-wide subsequent to an acquisition project
MEDA Pharma GmbH & Co KG
Bad Homburg
7 Jahre 6 Monate
2007-06 - 2014-11

Qualified Person & Quality Control Manager

  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly liquids and solid forms, moreover semi-solid forms
  • Training of staff for sampling and quality control
  • Up-dates of QOS for pharmaceut. dossiers (Module 2) for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors and suppliers
  • Maintenance of local quality assurance system with system of documents (SOPs and Working Procedures)
  • Audits of contract manufacturers and suppliers (DE and CH)
  • Processing, approval and co-signing of PQRs
  • Arrangements for stability tests of solid pharmaceutical forms with process validation experiments
GlaxoSmithKline Consumer HealthCare GmbH & Co KG (CHC)
1 Jahr 1 Monat
2013-07 - 2014-07

Supporting Quality Assurance units within project ? Inspection Readiness?

  • Drug substances, - Finished products
  • Review of deviations and quality related complaints
  • Root cause analysis, Final review and possible assignment of CAPA
  • Documentation by PC (MS Word, MS Excel, SAP)
Boehringer Pharma GmbH & Co KG
Ingelheim
4 Jahre 10 Monate
2009-09 - 2014-06

Qualified Person AMG/ EU & Quality Control Manager

  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly liquids and solid forms, moreover semi-solid forms
  • Training of staff for sampling and quality control
  • Up-dates of QOS for pharmaceut. dossiers (Module 2) for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors and suppliers
  • Maintenance of local quality assurance system with system of documents (SOPs and Working Procedures)
  • Audits of contract manufacturers and suppliers (DE and CH)
  • Processing, approval and co-signing of PQRs
  • Arrangements for stability tests of solid pharmaceutical forms with process validation experiments
GlaxoSmithKline CHC Herrenberg Site, changed into OMEGA Pharma Manufact. GmbH & Co KG
3 Jahre 6 Monate
2008-06 - 2011-11

Head of Manufacture and Qualified Person for project Andante®

  • Arrangements for the import of bulk drug product from Japan (MRA-country) and quality control of bulk product in Germany
  • Release of finished product after packaging and final product release for marketing
  • Provisions and establishing a quality assurance system in Germany for the import, manufacturing & quality control of Andante®
  • Technical agreements with supplier and evaluation of warehouse & distribution centre, - Filing/ establishing of PQR
Eisai GmbH
Frankfurt/ Main
2 Jahre 7 Monate
2005-01 - 2007-07

Quality Manager AMG & Qualified Person AMG/ EU

  • Arrangements for stability tests with for antibiotic formulations
  • Up-dates of pharmaceutical dossiers (Module 2, 3 ) and Quality-Declarations for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors
  • Audits of contract manufacturers with follow-up actions (DE, CH, GR, IT)
  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly solid forms, moreover parenteral forms (i.e. Hyaluronic acid, Thioctic acid)
  • Reception of quality related complaints and final response to patients and pharmacists, -Initiation and assignments of CAPA
MEDA GmbH, Wiesbaden and MEDA Pharma GmbH & Co KG, Bad Homburg
11 Jahre
1994-01 - 2004-12

Free Lance Regulatory & Pharmaceutical Affairs Services

  • European Drug Master Files (EDMFs) for active pharmaceutical ingredients and filing of pharmaceutical documentations incl. Expert Report/ Quality Overall
    Summary (QOS)
  • Mutual Recognition Procedures (CTD format) performed with several European Health Authorities
  • Development of a class III medical device accdg. to EC Guideline 93/42, i.e. pre-filled sterile syringe for intra-articular injections (Hyaluronic acid, sodium) incl. risk analysis and arrangements with contractors and suppliers
Pharma Resources GmbH
Ahrensburg, Basel, Dreieich
11 Jahre
1994-01 - 2004-12

Assistant Manager and Member of the Managing Board of a fine chemical company

  • Responsible Person for Manufacture/ Quality Control
    according to German Drug Law
  • Establishing a range of analytical reference standards for pharmaceutical analytical laboratories.
  • Review of Pharmaceutical Products and Renewals (Nachzulassung)
Roth GmbH
Karlsruhe-Germany
9 Jahre
1985-02 - 1994-01

Drug Registration Manager within the R&D Department

  • Responsible for the management of national and international applications for the approval of medicinal products
  • Multi State Procedures for Generics, national procedures for OTC-Products
  • Transdermal Systems: Duragesic
STADA AG
Bad Vilbel/ Germany
2 Jahre 4 Monate
1982-10 - 1985-01

Deputy Manager of Quality Control of a pharmaceutical company

  • Responsible for tasks of QC lab (part time) and pharmaceutical development (parttime, mainly developing tablets)
  • Processing and development of chemical-pharmaceutical dossiers
  • Co-operation with Syntex Pharmaceuticals within Project Naproxen-Sodium
Krewel Werke Arzneimittel GmbH
Eitorf/ Germany
4 Jahre
1978-10 - 1982-09

Head of a formulation lab of a pharmaceutical company

  • Development of OTC-Products (e.g. Spray-dry technology, encapsulation of essential oils)
  • Formulation of med. devices for urological use (Farco Pharma GmbH)
Klosterfrau/ Köln

Aus- und Weiterbildung

Aus- und Weiterbildung

02/1978

Warded Doctor title (Organic Chemistry, Biochemistry, Pharmaceutical Biology)

1976 -1979

Undergraduate studies in Pharmacy (1. Staatsexamen)

1975 -1978

Postgraduation and dissertation in Organic Chemistry

1970 - 1975

Undergraduate studies in Chemistry at Philipps-University/ Marburg

Kompetenzen

Kompetenzen

Top-Skills

Sachkundige Person AMG (QP) zur Chargenfreigabe, PQRs, GMP-Audits, RA:CMC-Projekte

Produkte / Standards / Erfahrungen / Methoden

  • MS Office-Items (Word, Excel, etc.)
  • SAP-Systems (R3, GCOMS, IBIS)
  • Docum. Systems
  • Trackwise

Einsatzorte

Einsatzorte

Frankfurt am Main (+100km) Cochem (+75km) Bonn (+75km) Darmstadt (+75km)
nicht möglich

Projekte

Projekte

4 Jahre 8 Monate
2020-03 - 2024-10

Sachkundige Person AMG/ Leiter d. QK

QP / L. d. Qk
QP / L. d. Qk
10 Monate
2019-03 - 2019-12

Prozessvalidierungen Downstreram im Biotech.-Bereich

QA-MAnager
QA-MAnager
Frankfurt/M.
3 Monate
2017-10 - 2017-12

Bewertung/ Trending analytischer Daten von Chargen für PQR/ APR

Trending Expert
Trending Expert
8 Monate
2016-08 - 2017-03

Supporting Quality Assurance, Directorate GMP and Inspections

PQR Manager
PQR Manager
  • Filing and establishing of PQRs/ APRs,  Particular chapters: assessment of analytical test results of batches with evaluation of trending charts (process verification), stability tests, deviation management and CAPA, final conclusion
Merck KG a. A.
Darmstadt
4 Monate
2016-02 - 2016-05

Supporting a QP Unit within Product Quality Assurance

  • Filing and establishing of PQRs/ APRs,
  • Particular chapters: compilation of analytical test results of manufactured batches with detailed assessment of trending charts (process verification), stability tests and complaints, deviation management and CAPA, final conclusion
Boehringer Pharma GmbH & Co KG
Ingelheim
11 Monate
2015-02 - 2015-12

Reg. Affairs Manager for national and international procedures (MRP/ DCP)

  • Maintenance and renewals of marketing authorisations, variations (Labelling, SmPC and technical-analytical changes within CMC documents )
  • MAH transfers world-wide subsequent to an acquisition project
MEDA Pharma GmbH & Co KG
Bad Homburg
7 Jahre 6 Monate
2007-06 - 2014-11

Qualified Person & Quality Control Manager

  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly liquids and solid forms, moreover semi-solid forms
  • Training of staff for sampling and quality control
  • Up-dates of QOS for pharmaceut. dossiers (Module 2) for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors and suppliers
  • Maintenance of local quality assurance system with system of documents (SOPs and Working Procedures)
  • Audits of contract manufacturers and suppliers (DE and CH)
  • Processing, approval and co-signing of PQRs
  • Arrangements for stability tests of solid pharmaceutical forms with process validation experiments
GlaxoSmithKline Consumer HealthCare GmbH & Co KG (CHC)
1 Jahr 1 Monat
2013-07 - 2014-07

Supporting Quality Assurance units within project ? Inspection Readiness?

  • Drug substances, - Finished products
  • Review of deviations and quality related complaints
  • Root cause analysis, Final review and possible assignment of CAPA
  • Documentation by PC (MS Word, MS Excel, SAP)
Boehringer Pharma GmbH & Co KG
Ingelheim
4 Jahre 10 Monate
2009-09 - 2014-06

Qualified Person AMG/ EU & Quality Control Manager

  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly liquids and solid forms, moreover semi-solid forms
  • Training of staff for sampling and quality control
  • Up-dates of QOS for pharmaceut. dossiers (Module 2) for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors and suppliers
  • Maintenance of local quality assurance system with system of documents (SOPs and Working Procedures)
  • Audits of contract manufacturers and suppliers (DE and CH)
  • Processing, approval and co-signing of PQRs
  • Arrangements for stability tests of solid pharmaceutical forms with process validation experiments
GlaxoSmithKline CHC Herrenberg Site, changed into OMEGA Pharma Manufact. GmbH & Co KG
3 Jahre 6 Monate
2008-06 - 2011-11

Head of Manufacture and Qualified Person for project Andante®

  • Arrangements for the import of bulk drug product from Japan (MRA-country) and quality control of bulk product in Germany
  • Release of finished product after packaging and final product release for marketing
  • Provisions and establishing a quality assurance system in Germany for the import, manufacturing & quality control of Andante®
  • Technical agreements with supplier and evaluation of warehouse & distribution centre, - Filing/ establishing of PQR
Eisai GmbH
Frankfurt/ Main
2 Jahre 7 Monate
2005-01 - 2007-07

Quality Manager AMG & Qualified Person AMG/ EU

  • Arrangements for stability tests with for antibiotic formulations
  • Up-dates of pharmaceutical dossiers (Module 2, 3 ) and Quality-Declarations for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors
  • Audits of contract manufacturers with follow-up actions (DE, CH, GR, IT)
  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly solid forms, moreover parenteral forms (i.e. Hyaluronic acid, Thioctic acid)
  • Reception of quality related complaints and final response to patients and pharmacists, -Initiation and assignments of CAPA
MEDA GmbH, Wiesbaden and MEDA Pharma GmbH & Co KG, Bad Homburg
11 Jahre
1994-01 - 2004-12

Free Lance Regulatory & Pharmaceutical Affairs Services

  • European Drug Master Files (EDMFs) for active pharmaceutical ingredients and filing of pharmaceutical documentations incl. Expert Report/ Quality Overall
    Summary (QOS)
  • Mutual Recognition Procedures (CTD format) performed with several European Health Authorities
  • Development of a class III medical device accdg. to EC Guideline 93/42, i.e. pre-filled sterile syringe for intra-articular injections (Hyaluronic acid, sodium) incl. risk analysis and arrangements with contractors and suppliers
Pharma Resources GmbH
Ahrensburg, Basel, Dreieich
11 Jahre
1994-01 - 2004-12

Assistant Manager and Member of the Managing Board of a fine chemical company

  • Responsible Person for Manufacture/ Quality Control
    according to German Drug Law
  • Establishing a range of analytical reference standards for pharmaceutical analytical laboratories.
  • Review of Pharmaceutical Products and Renewals (Nachzulassung)
Roth GmbH
Karlsruhe-Germany
9 Jahre
1985-02 - 1994-01

Drug Registration Manager within the R&D Department

  • Responsible for the management of national and international applications for the approval of medicinal products
  • Multi State Procedures for Generics, national procedures for OTC-Products
  • Transdermal Systems: Duragesic
STADA AG
Bad Vilbel/ Germany
2 Jahre 4 Monate
1982-10 - 1985-01

Deputy Manager of Quality Control of a pharmaceutical company

  • Responsible for tasks of QC lab (part time) and pharmaceutical development (parttime, mainly developing tablets)
  • Processing and development of chemical-pharmaceutical dossiers
  • Co-operation with Syntex Pharmaceuticals within Project Naproxen-Sodium
Krewel Werke Arzneimittel GmbH
Eitorf/ Germany
4 Jahre
1978-10 - 1982-09

Head of a formulation lab of a pharmaceutical company

  • Development of OTC-Products (e.g. Spray-dry technology, encapsulation of essential oils)
  • Formulation of med. devices for urological use (Farco Pharma GmbH)
Klosterfrau/ Köln

Aus- und Weiterbildung

Aus- und Weiterbildung

02/1978

Warded Doctor title (Organic Chemistry, Biochemistry, Pharmaceutical Biology)

1976 -1979

Undergraduate studies in Pharmacy (1. Staatsexamen)

1975 -1978

Postgraduation and dissertation in Organic Chemistry

1970 - 1975

Undergraduate studies in Chemistry at Philipps-University/ Marburg

Kompetenzen

Kompetenzen

Top-Skills

Sachkundige Person AMG (QP) zur Chargenfreigabe, PQRs, GMP-Audits, RA:CMC-Projekte

Produkte / Standards / Erfahrungen / Methoden

  • MS Office-Items (Word, Excel, etc.)
  • SAP-Systems (R3, GCOMS, IBIS)
  • Docum. Systems
  • Trackwise

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